Hi-Tech Pharmacal Ear Drop Recall: Missing Safety Seal
Hi-Tech Pharmacal recalls Hydrocortisone and Acetic Acid Otic Solution bottles due to missing tamper-evident safety seals. Check your lot number.
Use caution until it’s fixed
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Contact the company
What happened, in plain English
Akorn, Inc. is recalling Hi-Tech Pharmacal Hydrocortisone and Acetic Acid Otic Solution because the bottles are missing the required safety seal around the neck. The product label states it should be tamper-evident, but this specific lot lacks that approved component. This means the product does not match its labeling requirements for consumer safety. Read more at govinfonow.com/recall/43815-akorn-inc-recalls-hydrocortisone-and-acetic-acid-otic-solution-usp.
Source Summary by GovInfoNow · govinfonow.com/recall/43815-akorn-inc-recalls-hydrocortisone-and-acetic-acid-otic-solution-usp · Updated October 12, 2026 · FDA enforcement record: FDA #D-0295-2016
Cite this page
“Hi-Tech Pharmacal Ear Drop Recall: Missing Safety Seal.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43815-akorn-inc-recalls-hydrocortisone-and-acetic-acid-otic-solution-usp. Based on FDA recall #D-0295-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0295-2016%22&limit=1).
Why it’s dangerous
The hazard is that the bottle lacks the tamper-evident seal around the cap, which is intended to show if the product has been opened or compromised. While the record does not describe a specific injury mechanism like contamination or chemical harm, the missing seal means the product is inconsistent with its own labeling instructions regarding safety.
Who’s affected
Consumers who purchased Hi-Tech Pharmacal Hydrocortisone and Acetic Acid Otic Solution in 10 mL bottles nationwide or in Puerto Rico before August 21, 2015. Individuals using this prescription ear drop for ear conditions are the primary group affected.
How to tell if you have this one
Look for 10 mL bottles of Hydrocortisone and Acetic Acid Otic Solution, USP, manufactured by Hi-Tech Pharmacal. Check the label for NDC # 50383-901-10 and Lot # 346191 with an expiration date of 12/2016. Verify if the safety seal around the neck of the bottle is missing.
- Brand
Hi-Tech Pharmacal- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your bottle has Lot # 346191 and NDC # 50383-901-10, and check if the safety seal around the cap is missing.
Follow Label Instructions
The label indicates not to use the product if the printed seal around the cap is broken or missing; do not use this item if the seal is absent.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0295-2016 (August 21, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0295-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.